Perioperative myocardial ischemia and cytokine response in patients undergoing high-risk surgery; the influence of fluvastatin.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR899
• Date of registration: 12/02/2007
• Primary sponsor: Erasmus Medical Center, Department of Anesthesiology
• Public title: Perioperative myocardial ischemia and cytokine response in patients undergoing high-risk surgery; the influence of fluvastatin.
• Scientific title: Perioperative myocardial ischemia and cytokine response in patients undergoing high-risk surgery; the influence of fluvastatin. - DECREASE III
• Date of first enrolment: 1/7/2004
• Target sample size: 500
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=899
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: D. Poldermans

• Name: D. Poldermans

Key inclusion & exclusion criteria

Inclusion criteria: 1. Age > 40 years;

2. Scheduled for elective noncardiac surgery;

3. Risk score for perioperative;

4. Cardiovascular death ?d51 points;

5. Written informed consent.

Exclusion criteria: 1. Currently on statin therapy;

2. Contraindication for statin therapy;

3. Scheduled for surgery which interferes
with continuous 12-lead ECG recording,
such as thoracic and upper abdominal
surgery;

4. Unstable coronary disease;

5. Undergoing emergency surgery;

6. Patients with extensive stress-induced
ischemia during dobutamine stress test;

7. CK at baseline > 10x ULN;

8. Previous participation in the fluvastatin-
study;

9. Reoperation within 30 days of an initial
surgical procedure;

10. Participation in another clinical trial
within the last 30 days.


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Inflammation, Statin, Vascular surgery, Perioperative

Intervention(s)

Patients will come for an outpatient visit (= screening) approximately 30 days (= mean) prior to surgery. Informed consent will then be signed and in- and exclusion criteria will be checked. If the patient is eligible for the study, the patient will be randomised and subsequently study medication will be dispensed. Patients will be randomized to fluvastatin XL 80 mg or placebo once daily from randomization, approximately one month prior to surgery, to 30 days after surgery. A computer generated random number list will be used to randomise patients. All randomised patients are irrevocably in the study. They will be followed and analysed in the group to which they are allocated, regardless of whether or not they receive the assigned treatment or fulfil the eligibility criteria. The primary endpoint, myocardial ischemia, will be measured by continuous 12-lead ECG recording, starting on the evening prior to surgery up to 72 hours after surgery. Furthermore troponin release will be assessed on day 1, 3, 7 after surgery or at discharge.

Primary Outcome(s)

The primary endpoint is the occurrence of myocardial ischemia recorded during a 96-hour period using a 12-lead Rozing recorder. Ischemia is divided into pre, peri, and post-operative periods. The severity of ischemia in each period is scored as 'ischemic burden', reflecting the duration (minutes) and severity (ST-segment change from baseline) of ischemia.

Secondary Outcome(s)

1. Perioperative cytokine response. At screening, before the induction of anaesthesia, and after surgery cytokines are measured at 6, 24 hours after surgery, at 48, 72, and 96 hours after surgery; and 4, 5, 6, and 7 days after surgery;

2. Composite of cardiovascular death and myocardial infarction within 30 days after surgery.

Secondary ID(s)

ISRCTN83738615

N/A

Source(s) of Monetary Support

Erasmus Medical Center, Department of Anesthesiology